Alzheimer Disease, Dementia
Conditions
Brief summary
There is growing need for to provide high quality care for persons living with dementia (PLWD) and provide support for care partners in the primary care setting. The Care Ecosystem model is a telephone-based dementia care program that provides standardized, proactive, personalized, and scalable support and education for care partners. The Care Ecosystem model has demonstrated an improvement in patient quality of life, reduced unnecessary healthcare expenditures, and a decrease in care partner burden and depression. In this pilot the investigators will assess the feasibility of implementing and measuring outcomes of an adapted Care Ecosystem training model for primary care nurse managers serving a diverse panel of PLWD and their care partners in primary care practices participating in the Mass General Brigham healthcare system's Integrated Care Management Program in Boston, MA. The study team will leverage the Mass General Brigham electronic medical record to determine the feasibility of collecting the primary clinical outcome defined as emergency department visits among the PLWD cared for by the primary care practices. The investigative team will also assess the feasibility of implementation, number of contacts between nurse care managers and care partners, and documented advance care planning.
Interventions
The Care Ecosystem model uses a telephone-based intervention to support persons with dementia and their care partners, screening for common dementia-related problems and providing modular standardized support protocols and caregiver education. Specially trained health care navigators systematically identify needs and address health status, advance care planning, medication management and management of challenging behaviors. Health care navigators receive backup support from a nurse, social worker, dementia specialist, and pharmacist, and maintain close communication with the primary care provider of the persons with dementia. This Care Ecosystem model will be adapted to augment the dementia care provided by experienced Integrated Care Management Program nurse care managers engaged in the care of high-risk, high-cost patients in a large health system.
Sponsors
Study design
Eligibility
Inclusion criteria
* Medicare beneficiary aligned to the Partners Medicare ACO * ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020 (excluding diagnoses for diagnostic testing services) * Actively engaged in care management services with a nurse care manager enrolled in the study
Exclusion criteria
\- Permanent resident of long-term care or deceased at the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ED Visits Per Member Per Month 6 Months Post Intervention | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Distress (NPI-Q) 6 Months Post | 6 months | Mean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress. |
Countries
United States
Participant flow
Pre-assignment details
This is a pragmatic trial where nurse managers at various primary care practices were randomized to the control group which had delayed training or the intervention group which was the early intervention training. The enrollment number in the protocol section conflicts with the number of participants started in the flow module as some patients without a designated caregiver, who were deceased or who had moved to a skilled nursing facility were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Intervention- PWD Persons with Dementia Intervention: Patients of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. | 126 |
| Control- PWD Persons with Dementia Control: Patients of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. | 105 |
| Intervention- NCM Nurse Care Managers Intervention: Nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020. | 14 |
| Control- NCM Nurse Care Managers Control: Nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020. | 15 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 5 | 0 | 0 |
| Overall Study | Did not have at least 1 member month in pre and post period | 17 | 8 | 0 | 0 |
| Overall Study | Ineligible, health | 3 | 4 | 0 | 0 |
| Overall Study | Ineligible, language | 0 | 1 | 0 | 0 |
| Overall Study | Ineligible, no longer in care management | 0 | 2 | 1 | 0 |
| Overall Study | Ineligible, SNF | 2 | 2 | 0 | 0 |
| Overall Study | Missing identifier | 2 | 4 | 0 | 0 |
| Overall Study | No caregiver | 43 | 53 | 0 | 0 |
| Overall Study | No dementia | 13 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Control- PWD | Intervention- PWD | Control- NCM | Intervention- NCM | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 100 Participants | 126 Participants | 0 Participants | 0 Participants | 226 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 0 Participants | 15 Participants | 14 Participants | 34 Participants |
| Age, Continuous | 82.88 years STANDARD_DEVIATION 9.37 | 84.83 years STANDARD_DEVIATION 8.17 | — | — | 83.94 years STANDARD_DEVIATION 8.77 |
| ED Visits Per Member Per Month | 0.052 Visits per member per month STANDARD_DEVIATION 0.08 | 0.060 Visits per member per month STANDARD_DEVIATION 0.158 | — | — | 0.057 Visits per member per month STANDARD_DEVIATION 0.128 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 19 Participants | 0 Participants | 0 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 103 Participants | 0 Participants | 0 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 15 Participants | 14 Participants | 35 Participants |
| NPI-Q Distress Score | 9.29 Score on a scale STANDARD_DEVIATION 6.41 | 11.17 Score on a scale STANDARD_DEVIATION 9.27 | — | — | 10.33 Score on a scale STANDARD_DEVIATION 8.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 9 Participants | 0 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 24 Participants | 15 Participants | 14 Participants | 61 Participants |
| Race (NIH/OMB) White | 94 Participants | 93 Participants | 0 Participants | 0 Participants | 187 Participants |
| Region of Enrollment United States | 105 participants | 126 participants | 15 participants | 14 participants | 231 participants |
| Sex: Female, Male Female | 68 Participants | 82 Participants | 13 Participants | 12 Participants | 175 Participants |
| Sex: Female, Male Male | 37 Participants | 44 Participants | 2 Participants | 2 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 21 / 126 | 14 / 105 | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 0 / 126 | 0 / 105 | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 126 | 0 / 105 | 0 / 14 | 0 / 15 |
Outcome results
ED Visits Per Member Per Month 6 Months Post Intervention
Time frame: 6 months
Population: The analysis population for the primary outcome of Emergency Department visits includes all patients eligible for the baseline survey who had at least 1 member month during pre-intervention and post-intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ED Visits Per Member Per Month 6 Months Post Intervention | 0.056 Visits per member per month | Standard Deviation 0.129 |
| Control | ED Visits Per Member Per Month 6 Months Post Intervention | 0.075 Visits per member per month | Standard Deviation 0.144 |
Caregiver Distress (NPI-Q) 6 Months Post
Mean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress.
Time frame: 6 months
Population: The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Caregiver Distress (NPI-Q) 6 Months Post | 10.86 Score on a scale | Standard Deviation 8.79 |
| Control | Caregiver Distress (NPI-Q) 6 Months Post | 11.68 Score on a scale | Standard Deviation 8.6 |